Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02597933 · ClinicalTrials.gov registry record · Phase 3
A Trial to Compare Nintedanib With Placebo for Patients With Scleroderma Related Lung Fibrosis
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 580
- Enrollment target
NCT02597933 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 580 participants.
The verdict
NCT02597933, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 580 participants
- Enrollment target
Study Summary
Systemic Sclerosis (SSc) is a devastating disease of unknown etiology. Patients suffer from multiple organ fibrosis whereas lung fibrosis (interstitial lung disease, ILD) is one of the main driver for mortality. There is preclinical evidence for efficacy of nintedanib in SSc and associated ILD (SSc-ILD) and the anti-fibrotic efficacy of nintedanib was proven in idiopathic pulmonary fibrosis patients, who are presenting a similar pattern regarding lung fibrosis. Hence it is the purpose of the trial to confirm the efficacy and safety of nintedanib 150 mg bid in treating patients with SSc-ILD, compared with placebo. The trial will be conducted as a double blind, randomised, placebo-controlled trial with primary efficacy evaluation at week 52 and placebo-controlled treatment until last patient out (up to a maximum of 100 weeks). Respiratory function is globally accepted for assessment of treatment effects in patients with lung fibrosis. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is part of the usual examinations done in patients with SSc-ILD.
Interventions
- DRUG Placebo
- DRUG Nintedanib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 580 participants |
| Start Date | 2015-11-12 |
| Est. Completion | 2018-11-28 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02597933
The ClinicalTrials.gov registry entry for NCT02597933 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 580 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02597933 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02597933 about?
NCT02597933 is a clinical study titled "A Trial to Compare Nintedanib With Placebo for Patients With Scleroderma Related Lung Fibrosis". Systemic Sclerosis (SSc) is a devastating disease of unknown etiology. Patients suffer from multiple organ fibrosis whereas lung fibrosis (interstitial lung disease, ILD) is one of the main driver for mortality. There is preclinical evidence for efficacy of nintedanib in SSc and associated ILD (SSc-...
What is the current status of trial NCT02597933?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 580 participants. The study started on 2015-11-12. Estimated completion is 2018-11-28.
What interventions are being tested in trial NCT02597933?
The interventions under investigation include: Placebo (DRUG), Nintedanib (DRUG).
Who is sponsoring clinical trial NCT02597933?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.